Country Approval Specialist - FSP- Poland

Poland

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates must possess a Bachelor's degree or equivalent qualification and have previous experience demonstrating the necessary knowledge, skills, and abilities for the role. Equivalencies combining education, training, and experience may be considered. Effective oral and written communication skills, excellent interpersonal skills, and strong attention to detail are essential.

Responsibilities

The Country Approval Specialist will manage, prepare, review, and coordinate country submissions for investigative site activation in alignment with global strategies. This includes preparing and reviewing local regulatory submissions such as Ministry of Health (MoH) and Ethics Committee (EC) applications, and providing local regulatory strategy advice. The role involves coordinating with internal departments to align site start-up activities with submission timelines, maintaining accurate trial status information, and ensuring local study files are properly maintained according to standard operating procedures.

Skills

Regulatory Submissions

Attention to Detail

Accuracy

Clinical Trials

MoH Submissions

EC Submissions

Import License Applications

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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